CLARITIN Drug Patent Profile

Which patents cover Claritin, and when can generic versions of Claritin launch?

Claritin is a drug marketed by Bayer Healthcare Llc and is included in eight NDAs.

The generic ingredient in CLARITIN is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Claritin

A generic version of CLARITIN was approved as loratadine; pseudoephedrine sulfate by PERRIGO PHARMA INTL on January 30^th, 2003.

Summary for CLARITIN

US Patents:	0
Applicants:	1
NDAs:	8
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	148
Clinical Trials:	27
Patent Applications:	3,917
Drug Sales Revenues:	Drug sales revenues for CLARITIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLARITIN
What excipients (inactive ingredients) are in CLARITIN?	CLARITIN excipients list
DailyMed Link:	CLARITIN at DailyMed

See drug sales revenues for CLARITIN

Recent Clinical Trials for CLARITIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Andover Research Eye Institute	Phase 4
Rutgers, The State University of New Jersey	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all CLARITIN clinical trials

US Patents and Regulatory Information for CLARITIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN HIVES RELIEF	loratadine	TABLET;ORAL	019658-003	Nov 19, 2003		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN HIVES RELIEF REDITAB	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-003	Nov 19, 2003		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET, CHEWABLE;ORAL	021891-002	Nov 21, 2018		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN	loratadine	CAPSULE;ORAL	021952-001	Jun 16, 2008		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN REDITABS	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021993-001	Dec 12, 2006		OTC	Yes	Yes

Expired US Patents for CLARITIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002	6,132,758
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002	4,659,716*PED
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002	4,659,716*PED
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002	4,863,931*PED
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002	4,863,931*PED

International Patents for CLARITIN

See the table below for patents covering CLARITIN around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	019147	UNA FORMULACION DE JARABE QUE CONTIENE ANTIHISTAMINICO
Australia	638019
European Patent Office	0359499	Fluoro benzocycloheptapyridines, compositions et méthodes d'utilisation comme antihistaminiques (Fluoro substituted benzocycloheptapyridine compounds, compositions and methods of use as antihistaminic compounds)
Hungary	186774	PROCESS FOR PREPARING NEW ANTIHISTAMINES
Japan	S5735586	NOVEL ANTIHISTAMIC
Japan	S61289087	PRODUCTION OF PYPERIDILIDENE HYDRODIBENZO(A, D) CYCLOHEPTENES AND AZA DERIVATIVES THEREOF, COMPOUND OBTAINEDAND PHARMACEUTICAL COMPOSITION CONTAINING THE SAME
Spain	8300779

Supplementary Protection Certificates for CLARITIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
0152897	2001C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
0152897	C00152897/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0152897	SPC/GB01/012	United Kingdom		PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.

Market Dynamics and Financial Trajectory for Claritin

Introduction

Claritin, a widely recognized brand of the antihistamine loratadine, is a key player in the global allergy medication market. Here, we delve into the market dynamics and financial trajectory of Claritin, exploring the drivers, challenges, and future outlook of this prominent brand.

Market Size and Forecast

The Claritin market was valued at USD 0.16 billion in 2023 and is projected to reach USD 0.26 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.67% during the forecast period of 2024-2031[1][4].

Global Market Drivers

Several factors drive the growth of the Claritin market:

Product Innovation

Continuous research and development have led to novel formulations, including extended-release variants and combination medicines. These innovations enhance convenience and efficacy, appealing to consumers seeking better allergy relief[1].

Alterations in Lifestyle Factors

Urbanization and increased exposure to allergens such as pollen, dust mites, and pet dander have heightened the demand for allergy treatments. This shift in lifestyle factors contributes significantly to the market growth[1].

Seasonal Demand

Seasonal allergies, particularly during spring and autumn, result in increased demand for allergy relief medicines like Claritin. This seasonal variability is a consistent driver of sales[1].

Promotions and Marketing

Effective marketing strategies, including commercials and promotions, enhance brand awareness and stimulate sales. Strong marketing efforts by key players like Bayer AG and Johnson & Johnson play a crucial role in driving market growth[1].

Global Expansion

The expansion of Claritin into new markets and regions increases its consumer base and potential revenue. This geographical expansion is particularly significant in regions like Asia-Pacific, where there is a growing population and increased healthcare spending[1].

Market Challenges

Despite the growth drivers, the Claritin market faces several challenges:

Competition from Generic Brands

The presence of generic loratadine products at lower prices can constrain the market share of branded Claritin, impacting profitability. Generic alternatives often attract price-sensitive consumers, which can erode the market share of branded products[1].

Market Saturation

The antihistamine market is saturated with numerous established brands, making it challenging for Claritin to sustain growth. This saturation complicates marketing and distribution strategies[1].

Adverse Effects and Consumer Reservations

Some consumers may be reluctant to use antihistamines due to potential side effects, although Claritin is known for being non-drowsy. This consumer skepticism can hinder widespread acceptance[1].

Regulatory Challenges

Changes in legislation or constraints on advertising and marketing can influence the promotion and sale of Claritin. Regulatory hurdles can significantly impact the market dynamics[1].

Economic Factors

Economic recessions or fluctuations can affect consumer spending on healthcare products, including allergy medications. Economic instability can lead to reduced sales and market instability[1].

Changes in Consumer Preferences

Increasing trends towards natural and holistic health treatments may prompt consumers to seek alternatives to traditional drugs like Claritin. This shift in consumer preferences can challenge the market growth[1].

Market Segmentation Analysis

The global Claritin market is segmented based on product type, distribution channel, formulation, and geography.

Distribution Channels

Online retail has emerged as a dynamic sub-segment, experiencing significant growth due to increasing digital penetration and the convenience of home delivery. Health stores also play a crucial role, catering to health-conscious consumers who seek specialized products and personalized service[1].

Geographical Segmentation

The market is primarily categorized by geography, with key regions including North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. North America, particularly the United States and Canada, has significant market penetration due to strong brand recognition and high prevalence of allergic conditions. The Asia-Pacific region is emerging as a significant market driven by urbanization and increased healthcare spending[1].

Key Players

Major players in the Claritin market include:

• Bayer AG: Known for its strong performance in the consumer health segment, Bayer continues to drive growth through innovative products and effective marketing strategies[1][2][3].

• Sanofi: Another key player, Sanofi, contributes to the market through its diverse portfolio of healthcare products[1].

• Pfizer: Pfizer's presence in the market is significant, with a focus on new product launches and geographical expansion[1][3].

• Johnson & Johnson: Johnson & Johnson's consumer health division maintains dynamic growth, contributing to the overall market[1].

• Merck: Merck also plays a crucial role in the market with its range of healthcare products[1].

Financial Performance of Key Players

Bayer AG, one of the major players, reported significant growth in sales and earnings in 2022. Group sales increased by 8.7% on a currency- and portfolio-adjusted basis, reaching 50.739 billion euros. The consumer health division, which includes Claritin, maintained dynamic growth despite inflation-related cost increases[2].

Outlook and Future Growth

The Claritin market is expected to continue growing, driven by increasing prevalence of allergies, ease of access due to over-the-counter (OTC) availability, and ongoing product innovations. However, the market must navigate challenges such as competition from generic brands, regulatory hurdles, and changes in consumer preferences.

Seasonal Variability

The demand for allergy drugs exhibits significant seasonality, which can affect overall market stability. Effective marketing and distribution strategies are crucial to capitalize on seasonal demand[1].

Heightened Awareness of Drug Interactions

As consumers become more aware of potential drug interactions, some may refrain from using Claritin with other prescriptions, which could constrain its market. Addressing these concerns through education and product labeling is essential[1].

Key Takeaways

• The Claritin market is projected to grow at a CAGR of 5.67% from 2024 to 2031.
• Key drivers include product innovation, lifestyle changes, seasonal demand, and effective marketing.
• Challenges such as competition from generics, market saturation, and regulatory hurdles need to be addressed.
• Geographical expansion, particularly in the Asia-Pacific region, is a significant growth opportunity.
• Major players like Bayer AG and Pfizer continue to drive market growth through innovative products and strong marketing strategies.

FAQs

What is the projected market size of Claritin by 2031?

The Claritin market is expected to reach USD 0.26 billion by 2031[1][4].

What are the main drivers of the Claritin market?

The main drivers include product innovation, alterations in lifestyle factors, seasonal demand, and effective marketing and promotions[1].

Which region is expected to show significant growth in the Claritin market?

The Asia-Pacific region is emerging as a significant market due to urbanization, growing population, and increased healthcare spending[1].

What are the major challenges facing the Claritin market?

Challenges include competition from generic brands, market saturation, adverse effects and consumer reservations, regulatory challenges, and changes in consumer preferences[1].

Who are the key players in the Claritin market?

Major players include Bayer AG, Sanofi, Pfizer, Johnson & Johnson, and Merck[1].

Sources

1. Verified Market Research: Claritin Market Size, Share, Growth, Trends & Forecast.
2. Bayer: Significant growth in sales and earnings.
3. Mordor Intelligence: Loratadine Market - Size, Analysis, Industry Share & Growth.
4. Business Research Insights: Claritin Market Size, Share Growth and Forecast Till 2032.